BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 7094764 · Received December 7, 2017

    Report

    Report Number
    3002808486-2017-02357
    Event Type
    Injury
    Date Received
    December 7, 2017
    Report Date
    February 7, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    PMA / PMN Number
    K061670
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). ARTICLE: FOERST ET AL., "PERCUTANEOUS REPAIR OF LEFT VENTRICULAR WIRE PERFORATION COMPLICATING TRANSCATHETER AORTIC VALVE REPLACEMENT FOR AORTIC REGURGITATION", CARDIOVASCULAR INTERVENTION, 2016. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO ARTICLE: "THE FOLLOW-UP ECHOCARDIOGRAM WAS NOTABLE FOR A NEW LEFT VENTRICULAR APICAL PERFORATION WITH PSEUDOANEURYSM (PSA). THE PERFORATION WAS PRESUMED TO BE FROM THE MOTION OF THE DELIVERY SYSTEM DELIVERED OVER A SHAPED LUNDERQUIST WIRE (COOK MEDICAL). THE PSA ENLARGED OVER THE FOLLOWING 2 DAYS, SO GIVEN THE PATIENT¿S PROHIBITIVE SURGICAL RISK, WE DECIDED TO TREAT PERCUTANEOUSLY. AN 8-F TORQUE VIEW GUIDE (ST. JUDE MEDICAL) WAS ADVANCED TO THE LEFT VENTRICLE OVER A J WIRE THAT WAS DIRECTED INTO THE LEFT VENTRICULAR PSA. MULTIPURPOSE CATHETER WAS ADVANCED THROUGH THE TORQUE VIEW OVER THE J WIRE INTO THE PSA, AND THE DELIVERY CATHETER WAS ADVANCED OVER THE MULTIPURPOSE CATHETER. THE MULTIPURPOSE CATHETER AND WIRE WERE REMOVED, AND A 10-MM AMPLATZER MUSCULAR VENTRICULAR SEPTAL DEFECT OCCLUDER (ST. JUDE MEDICAL) WAS DEPLOYED. THERE WAS A TRIVIAL RESIDUAL LEAK. AT 4-MONTH FOLLOW-UP, THE PATIENT¿S DYSPNEA WAS IMPROVED AND THE PSA SPACE STABLE, WITH A SMALL RESIDUAL COLOR JET ON ECHOCARDIOGRAPHY." PATIENT OUTCOME: PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADVERSE EFFECTS ON THE PATIENT TO THIS OCCURRENCE: FORMATION OF A PSEUDOANEURYSM (A SECONDARY PROCEDURE WAS PERFORMED WHICH STABILISED THE PSEUDOANEURYSM).

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON ARTICLE AND IMAGE REVIEW. CTA AND ANGIOGRAPHIC IMAGES OF THE VENTRICULAR PSEUDOANEURYSM DEMONSTRATE A LEFT VENTRICULAR APICAL PSEUDOANEURYSM NECK JUST SUPERIOR TO A FOCUS AF APICAL THINNING. GIVEN THE HISTORY OF BYPASS GRAFTING TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE PERFORATION LIKELY OCCURRED AT THE SUPERIOR MARGIN OF AN APICAL SCAR. ALTHOUGH THE NECK DIAMETER MEASURED 4MM ON THE CTA IMAGE, IT WAS 5MM ON THE ANGIOGRAPHIC IMAGES. A VENTRICULAR PERFORATION CAUSING A PSEUDOANEURYSM IS CONFIRMED. THE REPORT IMPLICATES THE EVOLUT R DELIVERY SYSTEM RATHER THAN THE LUNDERQUIST WIRE AS THE CAUSE AND THE IMAGING PROVIDED SUPPORTS THAT CONCLUSION. THE WIRE WAS EITHER JUST PROJECTING BEYOND THE EVOLUT R TIP WHEN THE PERFORATION OCCURRED OR A TIGHT LOOP OF THE FLOPPY TIP WAS PUSHED BY THE EVOLUT R THROUGH A PARTIALLY THINNED LEFT VENTRICULAR APEX THAT WAS TOO WEAK TO BEND OR KINK THE WIRE. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED; ACUTE LEFT APICAL THINNING JUST INFERIOR TO THE PERFORATION SUPPORTS A VENTRICULAR APEX WEAKENED FROM SCARRING. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED; BECAUSE THE EVENT WAS NOT RECOGNIZED WHEN IT OCCURRED, EITHER ENOUGH WIRE WAS NOT PROJECTING OUT OF THE EVOLUT R WHEN THE PERFORATION OCCURRED OR A LOOP OF THE FLOPPY TIP WAS PUSHED THROUGH THE APEX WITHOUT BEING FLUOROSCOPICALLY OBSERVED. BASED ON THE ARTICLE/IMAGE REVIEW THERE IS NO EVIDENCE TO SUGGEST THAT THE LUNDERQUIST WIRE GUIDE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND PERFORMED AS INTENDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874430 LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE HAP WIRE GUIDE DQX WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening